At a glance
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A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)
In Brief
A Phase 2 clinical trial evaluating Vemurafenib, Obinutuzumab, and 2 other interventions for Hairy Cell Leukemia. Currently recruiting, targeting 86 participants across 10 sites.
Signals
Detailed Summary
The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.
Study Details
Timeline
Interventions
Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.
Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.
Cladribine IV on days 1-5 concurrently with rituximab.
Rituximab on days 1-5 concurrently with rituximab.